Vaccine Status and Hypogammaglobulinemia in N-MOmentum Trial Analyses: Bruce Cree, MD, PhD, MAS, FAAN

WATCH TIME: 3 minutes

“We're seeing a loss of gamma globulins that are nonspecific gamma globulins, or gamma globulins, perhaps that have not been directed against specific pathogens. Perhaps this is the reason that we're not seeing strong correlations between hypogammaglobulinemia and infections in inebilizumab treated patients.”

Since the FDA approval of inebilizumab (Uplizna; Horizon) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), there have been several new post-hoc analyses from the N-MOmentum trial, including 2 presented at the annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 23-25, 2023, in San Diego, California.^1,2 One analysis evaluated whether there was a correlation between the treatment and COVID infection risk and outcomes while the other investigated whether long-term B-cell depletion in patients being treated with inebilizumab affected the antibody levels from childhood vaccinations against measles, mumps, rubella, varicella-zoster and tetanus.³

In the first analysis, researchers observed a low incidence rate of infections among inebilizumab-treated patients, totaling 0.024 events per patient year.¹ Among 17 confirmed COVID infections reported, 10 of the cases were reported as serious, although the status of vaccination was not known. Of those patients, 6 were reported as “recovered/resolved,” 2 as not recovered/resolved and 2 patients died.

The second analysis showed that vaccine titers had no meaningful reduction after 3.5 years of treatment with inebilizumab.² Researchers conducted assay assessments to measure antibody titers associated with each vaccine at week 156 of the N-MOmentum trial, comparing the change from baseline among inebilizumab-treated versus placebo-treated participants.

At the forum, Bruce Cree, MD, PhD, MAS, FAAN, the clinical research director of the UCSF Multiple Sclerosis Center, sat down for an interview with NeurologyLive® to provide more detail on the findings presented. In addition, he shared his thoughts on what the results mean for patients with NMOSD in their health outcomes.

Click here for more coverage of ACTRIMS 2023.

REFERENCES
1. Hartung H, Weinshenker B, Pittock S, et al. Effect of Inebilizumab on Vaccine-Generated Antibody Titers in NMOSD Participants: Results from N-MOmentum study. Presented at ACTRIMS Forum 2023; February 23-25; San Diego, California. Abstract P316.
2. Cree B, Rensel MR, Pittock S, et al. Clinical Outcomes of COVID-19 Infection Among Patients with NMOSD Receiving Inebilizumab Treatment in the N-Momentum Trial and Safety Database in the United State. Presented at ACTRIMS Forum 2023; February 23-25; San Diego, California. Abstract P314.
3. New Data Suggest UPLIZNA (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Did Not Increase the Risk of COVID-19 Infection or Reduce Antibody Levels From Childhood Vaccines. Horizon Therapeutics. Published February 23, 2023. Accessed March 1, 2023. https://www.businesswire.com/news/home/20230223005284/en/New-Data-Suggest-UPLIZNA%C2%AE-inebilizumab-cdon-for-the-Treatment-of-Neuromyelitis-Optica-Spectrum-Disorder-NMOSD-Did-Not-Increase-the-Risk-of-COVID-19-Infection-or-Reduce-Antibody-Levels-From-Childhood-Vaccines